Teva Respiratory reports positive results from BDP HFA Nasal Aerosol Phase III trial in seasonal allergic rhinitis

Teva Respiratory today announced positive results from a Phase III trial evaluating the efficacy and safety of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) Nasal Aerosol in the treatment of seasonal allergic rhinitis (SAR). The study met all efficacy endpoints, demonstrating a statistically significant benefit as compared to placebo. Furthermore, the safety profile of BDP HFA Nasal Aerosol was similar to placebo.

"The outcomes of the Phase III SAR trial validate the potential of BDP HFA as a treatment option for patients trying to manage their nasal allergies," said Mark Salyer, General Manager of Teva's Respiratory Division. "The goal of this development program is to address the unmet clinical need among the 60 million Americans affected with allergic rhinitis who are looking for a solution that delivers a 'dry' experience to avoid the 'wet feeling' and postnasal drip associated with the nasal spray formulations that are available today."

Currently, the intranasal spray (INS) market is composed only of aqueous or "wet feeling" products; however, prior to the U.S. Food and Drug Administration's (FDA) decision to phase out metered dose inhalers (MDIs) that contain chlorofluorocarbons (CFCs), the nasal market also included aerosol or "dry formulation" sprays. Teva's Nasal Aerosol utilizes an HFA propellant. Future studies will further examine the safety and efficacy profile of this product.

Based on results from the Phase I study that evaluated the pharmacokinetics, safety and tolerability of BDP HFA, the systemic exposure following administration of the treatment (up to 320 mcg/day) was approximately 27 percent of orally inhaled BDP HFA, which is marketed by Teva as the asthma treatment QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol. Based on these results, the established QVAR® safety data may provide further supportive evidence for the development of this "dry" nasal formulation for the treatment of allergic rhinitis.